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Cocaine/Crack and Reduction of Compulsion With Biperiden

Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence; Crack Dependence

Intervention: Biperiden (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Federal University of São Paulo

Overall contact:
José C.F. Galduróz, MD/PhD, Phone: +5511-2149-0168, Email: galduroz@psicobio.epm.br

Summary

Cocaine consumption affects around 13. 4 mi people or 0. 3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.

Clinical Details

Official title: Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Compulsion score

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

Exclusion Criteria:

- Being under treatment with psychoactive drugs

- Have been diagnosed for other Psychiatric Disorders

- Have dependence diagnosis for other drugs, except for tabacco

Locations and Contacts

José C.F. Galduróz, MD/PhD, Phone: +5511-2149-0168, Email: galduroz@psicobio.epm.br

UDED - Drug Dependence Unit, São Paulo 04024-003, Brazil; Recruiting
Maria Lucia O.S. Formigoni, PhD, Phone: +5511-5549-2500, Email: mlformig@psicobio.epm.br
Additional Information

Starting date: May 2011
Last updated: June 21, 2011

Page last updated: December 08, 2011

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